[NP-ADMP1-C2] Post Diploma Certificate in Pharmaceutical Quality Systems - Part of Advanced Diploma in Medical and Pharmaceutical Technology (ADMP1)

Offered by School of Life Sciences & Chemical Technology

Advanced Diploma

About Course
Course Schedule
Course Structure
Entry Requirements
Financial Matters

About Course

Course Objectives

The PDC in Pharmaceutical Quality Systems focuses on GMP requirements, quality assurance systems and the analytical techniques essential in product quality control for the manufacturing of pharmaceuticals, biopharmaceuticals and medical devices.

Course Description

The Post Diploma Certificate in Pharmaceutical Quality Systems - Part of Advanced Diploma in Medical and Pharmaceutical Technology (ADMP1) is a part-time CET course, consist of the following modules:
1. cGMP Compliance (36 hrs)
2. QC & Pharmaceutical Analytics (36 hrs)
3. Validation (36 hrs)
4. QA & Documentation (45 hrs)

Course 
Schedule

Class Day(s) :  Mon - Fri (3 to 4 evenings a week)
Time: 6:30pm to 10:00pm
Delivery mode: Face-to-face & Home-based Learning (Async & Sync)

Course Structure

TPG course reference No.

TGS-2022014350

Post-Diploma Certificate in Pharmaceutical Quality Systems
QA & Documentation (NP-013218)
The module will cover documentation and its role in Quality Assurance in pharmaceutical manufacturing. Documentation requirements under GMP, ISO Quality Management System and ICH guidelines will be compared. International quality and regulatory requirements including those of the HSA will be compared. The module will cover documentation requirements for quality events including customer complaints, Out of Specifications, Deviation Investigations, Root Cause Analysis and Corrective Action Preventative Action. The topic of documentation requirements for Qualification and Validation will cover Change Control, IQ, OQ and PQ, method validation for incoming materials, process control and finished product quality. The components of the QA Documentation System and Good Documentation Practice will be covered. The module will also cover Quality Audits, regulatory inspections and interpreting and responding to FDA 483 Warning Letters.
QC & Pharmaceutical Analytics (NP-013216)
This module studies analytical techniques used for the detection, identification and quantitative determination of drugs and related substances. Techniques for the evaluation of analytical data and validation of analytical methods will be introduced as well as an overview of QC issues and regulatory requirements related to the quality of biopharmaceuticals.
Validation (NP-013217)
The module will cover the principles and practices of Validation providing an introduction to organization of the validation process. Topics will include validation of critical utilities, cleaning and sterilization, methods, computer systems and processes. The validation of biopharmaceutical processes will also be covered.
cGMP Compliance (NP-013215)
The module will provide an overview of the GXP regulatory standards and requirements in pharmaceutical industry and starting with the drug development process to the production of the finished product. GMPs and the Quality Management Systems covering organization and personal, equipment and facilities, contamination control, documentation management, packaging and labeling and API and biologics manufacturing will be covered.

Entry Requirements

Condition 1

Highest qualification

Local Polytechnic Diploma/ Degree in technical disciplines such as Science, Engineering or Information Technology.
and

Highest qualification

-
or

Condition 2

Highest qualification

Local Polytechnic Diploma or Degree in a non-engineering / non-technology disciplines.
and

Highest qualification

A Credit or a minimum grade of C6 in GCE “O” level Science Subject.

Financial matters

Course fees payable (incl. GST & excl. supplementary fee)

Description Post-Diploma Certificate in Pharmaceutical Quality Systems Total course fee
Full Course fee $3,802.36 $3,802.36
Singapore Citizen Aged 40 & Above $380.24 $380.24
PR Sponsored by SME $395.93 $395.93
Singapore Citizen Sponsored by SME $395.93 $395.93
Singapore Citizen Aged Below 40 $570.35 $570.35
Singapore PR $1,520.94 $1,520.94
Long-Term Visit Pass Plus $3,802.36 $3,802.36

GST rate

The course fees payable above are inclusive of 9% GST rate.

Payment option

The first payment needs to be made after accepting the offer.

Allowed payment by

Post-Secondary Education Account (Adhoc withdrawal form);Post-Secondary Education Account (Standing order form);SkillsFuture Credits (SFC);Credit card (e-payment);Debit card (e-payment);PayNow (e-payment)

Nett Supplementary Fees Payable

  • GPA Insurance Fee S$2.13,subject to GST,fees payable S$2.32 Allow payment by Post-Secondary Education Account (Adhoc withdrawal form); Allow payment by Post-Secondary Education Account (Standing order form)
  • Other Fees S$7.50,subject to GST,fees payable S$8.18 Allow payment by Post-Secondary Education Account (Adhoc withdrawal form); Allow payment by Post-Secondary Education Account (Standing order form)

Refund and withdrawal policy

  • Please note that a 100% refund will be available if the withdrawal request is submitted more than or equal to 14 days before the course start date.
  • Please note that a 50% refund will be available if the withdrawal request is submitted less than 14 days before the course start date.
  • Please note that no refund will be available if the withdrawal request is submitted on or after the course start date.